Two multi-center studies evaluating locally delivered doxycycline hyclate, placebo control, oral hygiene, and scaling and root planing in the treatment of periodontitis

Steven Garrett, Lonnie Johnson, Connie Hastings Drisko, Donald F. Adams, Carl Bandt, Bradley Beiswanger, Gary Bogle, Kevin Donly, William W. Hallmon, E. Brady Hancock, Philip Hanes, Charles E. Hawley, Robert Kiger, William Killoy, James T. Mellonig, Alan Polson, Frank J. Raab, Mark Ryder, Norman H. Stoller, Hom Lay WangLawrence E. Wolinsky, Gerald H. Evans, Charles Q. Harrold, Ralph M. Arnold, David F. Atack, Bryan Fitzgerald, Margaret Hill, Roger L. Isaacs, Hisham F. Nasi, Donald H. Newell, R. Lamont MacNeil, Simon MacNeill, Vladimir W. Spolsky, Susan P. Duke, Anne Polson, G. Lee Southard

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117 Scopus citations

Abstract

Background: The clinical efficacy and safety of doxycycline hyclate (8.5% w/w) delivered subgingivally in a biodegradable polymer (DH) was compared to placebo control (VC), oral hygiene (OH), and scaling and root planing (SRP) in 2 multi-center studies. Method: Each study entered 411 patients who demonstrated moderate to severe periodontitis. Patients had 2 or more quadrants each with a minimum of 4 qualifying pockets ≥5 mm that bled on probing. At least 2 of the pockets were ≥7 mm. Treatment with DH, VC, OH, or SRP was provided at baseline and again at month 4. Clinical parameters were recorded monthly. Results: DH and SRP resulted in nearly identical clinical changes over time in both studies. Mean 9 month clinical attachment level gain (ALG) was 0.8 mm for the DH group and 0.7 mm for the SRP group in Study 1, and 0.8 mm (DH) and 0.9 mm (SRP) in Study 2. Mean probing depth (PD) reduction was 1.1 mm for the DH group and 0.9 mm for the SRP group in Study 1 and 1.3 mm for both groups in Study 2. Frequency distributions showed an ALG ≥2 mm in 29% of DH sites versus 27% of SRP sites in Study 1 and 31% of DH sites versus 34% of SRP sites in Study 2. PD reductions ≥2 mm were seen in 32% of DH sites versus 31% of SRP sites in Study 1 and 41% of DH sites versus 43% of SRP sites in Study 2. Comparisons between DH, VC, and OH treatment groups showed DH treatment to be statistically superior to VC and OH. Safety data demonstrated a benign safety profile with use of the DH product. Conclusions: Results of this trial demonstrate that treatment of periodontitis with subgingivally delivered doxycycline in a biodegradable polymer is equally effective as scaling and root planing and superior in effect to placebo control and oral hygiene in reducing the clinical signs of adult periodontitis over a 9-month period. This represents positive challenges resulting from the use of subgingivally applied doxycycline as scaling and root planing was not limited regarding time of the procedure or use of local anesthesia.

Original languageEnglish (US)
Pages (from-to)490-503
Number of pages14
JournalJournal of periodontology
Volume70
Issue number5
DOIs
Publication statusPublished - May 1999

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Keywords

  • Doxycycline/therapeutic use
  • Drug delivery systems
  • Multi-center studies
  • Periodontitis/drug therapy

ASJC Scopus subject areas

  • Periodontics

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